Melatonin Treatment for Tardive Dyskinesia in Schizophrenia

July 10, 2016 updated by: Xiang Yang Zhang, Beijing HuiLongGuan Hospital

The Effect of Melatonin Treatment on Tardive Dyskinesia and Oxidative Stress: A Double-Blind Placebo-Controlled Trial

This is a double-blind, randomized, placebo-controlled trial of melatonin as an add-on therapy to antipsychotics will be performed to examine the effects of melatonin on tardive dyskinesia symptoms and cognitive deficits in 120 patients with established tardive dyskinesia (TD). This study addresses a free radical hypothesis of TD.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

  1. Since it has been proposed that neuroleptic-induced increases in free-radical production may relate to the development of TD, the investigators hypothesize that melatonin, an effective antioxidant, may attenuate the severity of tardive dyskinesia symptoms.
  2. Due to increased cognitive deficits in patients with TD and implication of oxidative stress in cognitive impairment, the investigators hypothesize that both cognitive impairment and tardive dyskinesia symptoms may be induced by the same pathophysiological stimulus--oxidative stress. Hence, the investigators further hypothesize that both tardive dyskinesia symptoms and cognitive deficits in patients with TD may be improved by melatonin simultaneously.

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Beijing, China, 100096
        • Beijing HuiLongGuan Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 66 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. diagnosis of both schizophrenia and TD;
  2. duration of TD symptoms longer than 1 year;
  3. on stable doses of antipsychotic drug for at least 6 months;
  4. between 18 and 70 years of age.

Exclusion Criteria:

  1. comorbid neurological illness other than TD;
  2. if they have received vitamin C or vitamin E within 1 month before the start of the study;
  3. alcohol/drug abuse;
  4. acute, unstable medical condition;
  5. pregnant or breastfeeding female;
  6. use of other antioxidants.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Melatonin, antioxidant, oxidative stress
Melatonin is an active treatment for TD.
Drug: Melatonin
10mg/day, 12-week treatment
Other Names:
  • APRD00742
Placebo Comparator: Placebo
Placebo look like the active drug, and same dose.
Drug: Placebo
10mg/day, 12-week treatment for TD

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
the Abnormal Involuntary Movement Scale (AIMS)
Time Frame: 12 weeks
12 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)
Time Frame: 12 weeks
12 weeks
the Positive and Negative Syndrome Scale (PANSS)
Time Frame: 12 weeks
12 weeks
the Simpson-Angus Scale for extrapyramidal side effects (SAS)
Time Frame: 12 weeks
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beijing HuiLongGuan Hospital

Collaborators

Stanley Medical Research Institute

Investigators

  • Study Chair: Lian Y Cao, MD, Beijing HuiLongGuan Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2008

Primary Completion (Actual)

April 1, 2011

Study Completion (Actual)

May 1, 2011

Study Registration Dates

First Submitted

July 7, 2011

First Submitted That Met QC Criteria

July 11, 2011

First Posted (Estimate)

July 12, 2011

Study Record Updates

Last Update Posted (Estimate)

July 12, 2016

Last Update Submitted That Met QC Criteria

July 10, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BJ-7072035

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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